There is considerable literature on the existence of squamous cell carcinoma and the diagnostic value of a tumor antigen of the squamous cell carcinoma (often referred to as TA-4 or its subfraction SCC).
The SCC antigen and TA-4 which have been referred to in the literature have been extracted from either the actual squamous cell carcinoma itself, a carcinoma cell line derived therefrom or from serum which is found in patients who have squamous cell carcinoma. There are inherent difficulties in using these materials, namely the difficulty and hazard of handling the actual carcinoma tissue and the low concentration of TA-4 which appears in serum or cell lines. Thus the difficulty in handling the current sources of these antigens makes the production of these materials and of products utilizing the SCC antigen and TA-4 (e.g., reference materials) very difficult and expensive.
Previous work by the current inventor (35 Clin. Chem. (1989) 1079) also identified SCC-like material in seminal plasma and amniotic fluid. Although present in concentrations above that found in serum, the difficulty of obtaining these fluids make them impractical as commercial sources.
This invention relates to the identification of an SCC-like material in human female urine. This material is present in urine in a much higher level than that in normal human serum and can be isolated without encountering the difficulties of handling the other human materials. The identification of the SCC-like material in urine has led to the ability to isolate a material which is much less expensive to produce than the previous materials and methods and which has been found to be as useful as the previous materials.
The invention covers not only the identification of the material but also techniques for isolation and use of the SCC-like material.